Alembic Pharma rises after final USFDA nod for anti-infective gel


Alembic Pharmaceuticals gained 1.12% to Rs 783.15 after the drug maker announced that its joint venture, Aleor Dermaceuticals, received final approval from the US drug regulator for metronidazole gel.
Metronidazole gel USP is indicated for the topical treatment of inflammatory lesions of rosacea.
Aleor had previously received tentative approval for this Abbreviated New Drug Application (ANDA). The approved ANDA is therapeutically equivalent to the reference listed drug product Metrogel Gel 1%, of Galderma Laboratories LP.
According to IQVIA, metronidazole gel USP has an estimated market size of $29 million for twelve months ending June 2021.
Alembic has a cumulative total of 149 ANDA approvals (132 final approvals and 17 tentative approvals) from USFDA.
Aleor is a 60:40 joint venture between Alembic and Orbicular Pharmaceutical Technologies formed in Apr 2016 focusing on commercialising dermatology products globally.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. The drug maker's consolidated net profit dropped 45.42% to Rs 164.52 crore on a 1.13% fall in revenue from operations to Rs 1,326.03 crore in Q1 FY22 over Q1 FY21.

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First Published: Sep 6 2021 | 1:51 PM IST

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